Arrowwind
15th February 2012, 15:01
FDA Animals at it AGAIN. Crooks, thieves, imposters and frauds who will intentionally harm US citizens
Full Story Here: http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1
By Dr. Mercola
The U.S. Food and Drug Administration (FDA) secretly monitored the personal e-mail of nine whistleblowers—its own scientists and doctors—over the course of two years.
The monitored employees had warned Congress that the agency was approving medical devices that posed unacceptable risks to patients.
Six of the monitored scientists and doctors recently filed a lawsuit against the FDA, charging that the agency violated their constitutional rights to privacy by monitoring lawful activity in personal email accounts, and using that information to harass and ultimately relieve some of them of their positions.
According to the Washington Post1 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn1):
"All had worked in an office responsible for reviewing devices for cancer screening and other purposes.
Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins.
The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers."
The FDA has declined to comment on the allegations, stating it does not comment on cases involved with litigation.
However, according to internal FDA documents obtained by the plaintiffs under the Freedom of Information Act, the agency had asked the Department of Health and Human Services' (DHHS) inspector general to conduct an investigation back in May 2010, stating suspicions that the plaintiffs had improperly disclosed confidential business information about the devices.
The HHS inspector general's office found no evidence of criminal conduct, stating the doctors and scientists had legal right to share their concerns with Congress and journalists.
Hence no investigation was launched. But the FDA was not satisfied.
On June 28 that same year, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health wrote that, "We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," and again requested action be taken against the employees in question. (Shuren is also the official who oversees mercury dental fillings, which they have been fraudulently referring to as 'silver fillings'. Shuren had promised to make an announcement about dental amalgam (http://articles.mercola.com/sites/articles/archive/2012/01/17/fda-action-on-dental-amalgam.aspx)by the end of 2011. But with just six minutes left in the work year, at 4:54 pm on Friday, December 30, the FDA conceded that no announcement was forthcoming – not in 2011, and maybe not at all.)
After consulting with general prosecutors, the inspector general declined the second request for an investigation as well. Now the question is whether the agency monitored their employees within legal limits, and whether the purpose of the extensive monitoring was reasonable.
Senator Charles Grassley doesn't seem to think so, stating that:
"The FDA has a huge responsibility to protect public health and safety. It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress."
Systemic Corruption and Wrongdoing...
Although its roots go way further back, the current saga began in 2007, when the plaintiffs, all of whom worked for the FDA's Office of Device Evaluation, claim they began making internal complaints about a dozen radiological devices about to be approved despite lack of proof of effectiveness. The doctors and scientists were concerned that millions of patients would be put at risk. According to the featured article:
Three devices risked missing signs of breast cancer
One device risked falsely diagnosing osteoporosis
One ultrasound device could malfunction while monitoring pregnant women in labor
Several colon cancer screening devices employed such heavy doses of radiation that they risked causing cancer in otherwise healthy people
They also recommended against approval of a computer-aided imaging device for breast cancer screening a total of three times. But after the third rejection, a senior manager, Donna-Bea Tillman, suddenly approved the device in 2008. This and much more was detailed in a 2009 letter from an unknown number of FDA employees to President Obama's transition team.2 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn2),3 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn3) In that letter (in which all the signatures were blacked out due to fear of retaliation from the FDA), the authors clearly spell out the need for a complete overhaul of the agency due to deep-rooted systemic corruption at the highest levels.
They write:
"On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta: Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out.
Currently there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. ... America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re-establishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation."
Remarkably, just two months later, Acting Commissioner Dr. Frank M. Torti and FDA attorneys sent an email to all FDA employees stating they "must comply with … obligations to keep certain information … confidential … e-mail to and from employees within FDA [that document the] deliberative process." Furthermore, employees were told that "violation … can result in disciplinary sanctions and/or individual criminal liability."
A few days later, on March 24, 2009, Senator Grassley sent a letter to Dr. Torti stating that:
[I]"Your memorandum … appears to run contrary to many statutes protecting executive branch communications with members of Congress… I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA's regulatory mission. [This] could be viewed … as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws."
Congressional Hearing on Mammography Cover-Up is Overdue
Folks, this is a major story, and it's about to get much bigger... There's loads of powerful and damning information out there that can, and will, be used to call for a congressional hearing on the mammography cover-up. Decades ago, in 1974, the National Cancer Institute (NCI) was warned by professor Malcolm C. Pike at the University of Southern California School of Medicine that a number of specialists had concluded that "giving a women under age 50 a mammogram on a routine basis is close to unethical."
And in the 1990's, Dr. Samuel Epstein started warning people about the dangers of mammography, stating:
"The premenopausal breast is highly sensitive to radiation, each 1 rad exposure increasing breast cancer risk by about 1 percent, with a cumulative 10 percent increased risk for each breast over a decade's screening... The high sensitivity of the breast, especially in young women, to radiation-induced cancer was known by 1970. Nevertheless, the establishment then screened some 300,000 women with X-ray dosages so high as to increase breast cancer risk by up to 20 percent in women aged 40 to 50 who were mammogramed annually."
Since then, concerned FDA doctors and scientists have issued a number of written warnings in the form of letters to various authorities, such as the October 2008 letter to Representative Dingell, notifying him of corruption within the FDA, which sparked a House Energy and Commerce Committee investigation intoCenter for Devices and Radiological Health(CDRH) activities. 4 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn4)
A second letter, sent in January 2009 to HHS Secretary-Designate Tom Daschle, Baltimore City Health Department Chief Joshua Sharfstein, and nine members of Congress, delved into more detail. According to Medical Devices Today5 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn5):
"In the case of an April 2008 approval of a computer-aided detection device for mammography, the scientists specifically charge (by title, but not by name) ODE Director Donna-Bea Tillman "and her subordinates" with the "most outrageous misconduct by ordering, coercing, and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."
The letter also includes a bullet-pointed list of nine "examples of wrongdoing" by the ODE Director, including ordering physicians and scientists to ignore FDA guidance documents and allowing manufacturers to market unapproved devices."
In October that same year (2009), the US Preventative Task Force revised its recommendations on mammograms,6 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn6) stating that women in their 40's should no longer get routine mammograms for early detection of breast cancer. Instead, the panel recommended waiting until the age of 50, and only doing one mammogram every other year, instead of yearly. They also suggested women between 40 to 49 should talk to their doctor about the risks and benefits of the test, and then decide if they want to be screened. The Canadian task force followed suit in November last year.7 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn7)
Many cancer organizations were outraged and have shunned the task forces' new directive; completely ignoring the data supporting their decision... The main reason behind the changed guidelines? The inherent dangers and short-comings of mammographic screening...
__________________
Full Story Here: http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1
By Dr. Mercola
The U.S. Food and Drug Administration (FDA) secretly monitored the personal e-mail of nine whistleblowers—its own scientists and doctors—over the course of two years.
The monitored employees had warned Congress that the agency was approving medical devices that posed unacceptable risks to patients.
Six of the monitored scientists and doctors recently filed a lawsuit against the FDA, charging that the agency violated their constitutional rights to privacy by monitoring lawful activity in personal email accounts, and using that information to harass and ultimately relieve some of them of their positions.
According to the Washington Post1 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn1):
"All had worked in an office responsible for reviewing devices for cancer screening and other purposes.
Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins.
The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers."
The FDA has declined to comment on the allegations, stating it does not comment on cases involved with litigation.
However, according to internal FDA documents obtained by the plaintiffs under the Freedom of Information Act, the agency had asked the Department of Health and Human Services' (DHHS) inspector general to conduct an investigation back in May 2010, stating suspicions that the plaintiffs had improperly disclosed confidential business information about the devices.
The HHS inspector general's office found no evidence of criminal conduct, stating the doctors and scientists had legal right to share their concerns with Congress and journalists.
Hence no investigation was launched. But the FDA was not satisfied.
On June 28 that same year, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health wrote that, "We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law," and again requested action be taken against the employees in question. (Shuren is also the official who oversees mercury dental fillings, which they have been fraudulently referring to as 'silver fillings'. Shuren had promised to make an announcement about dental amalgam (http://articles.mercola.com/sites/articles/archive/2012/01/17/fda-action-on-dental-amalgam.aspx)by the end of 2011. But with just six minutes left in the work year, at 4:54 pm on Friday, December 30, the FDA conceded that no announcement was forthcoming – not in 2011, and maybe not at all.)
After consulting with general prosecutors, the inspector general declined the second request for an investigation as well. Now the question is whether the agency monitored their employees within legal limits, and whether the purpose of the extensive monitoring was reasonable.
Senator Charles Grassley doesn't seem to think so, stating that:
"The FDA has a huge responsibility to protect public health and safety. It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their e-mail accounts for legally protected communications with Congress."
Systemic Corruption and Wrongdoing...
Although its roots go way further back, the current saga began in 2007, when the plaintiffs, all of whom worked for the FDA's Office of Device Evaluation, claim they began making internal complaints about a dozen radiological devices about to be approved despite lack of proof of effectiveness. The doctors and scientists were concerned that millions of patients would be put at risk. According to the featured article:
Three devices risked missing signs of breast cancer
One device risked falsely diagnosing osteoporosis
One ultrasound device could malfunction while monitoring pregnant women in labor
Several colon cancer screening devices employed such heavy doses of radiation that they risked causing cancer in otherwise healthy people
They also recommended against approval of a computer-aided imaging device for breast cancer screening a total of three times. But after the third rejection, a senior manager, Donna-Bea Tillman, suddenly approved the device in 2008. This and much more was detailed in a 2009 letter from an unknown number of FDA employees to President Obama's transition team.2 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn2),3 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn3) In that letter (in which all the signatures were blacked out due to fear of retaliation from the FDA), the authors clearly spell out the need for a complete overhaul of the agency due to deep-rooted systemic corruption at the highest levels.
They write:
"On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta: Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out.
Currently there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. ... America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re-establishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation."
Remarkably, just two months later, Acting Commissioner Dr. Frank M. Torti and FDA attorneys sent an email to all FDA employees stating they "must comply with … obligations to keep certain information … confidential … e-mail to and from employees within FDA [that document the] deliberative process." Furthermore, employees were told that "violation … can result in disciplinary sanctions and/or individual criminal liability."
A few days later, on March 24, 2009, Senator Grassley sent a letter to Dr. Torti stating that:
[I]"Your memorandum … appears to run contrary to many statutes protecting executive branch communications with members of Congress… I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA's regulatory mission. [This] could be viewed … as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws."
Congressional Hearing on Mammography Cover-Up is Overdue
Folks, this is a major story, and it's about to get much bigger... There's loads of powerful and damning information out there that can, and will, be used to call for a congressional hearing on the mammography cover-up. Decades ago, in 1974, the National Cancer Institute (NCI) was warned by professor Malcolm C. Pike at the University of Southern California School of Medicine that a number of specialists had concluded that "giving a women under age 50 a mammogram on a routine basis is close to unethical."
And in the 1990's, Dr. Samuel Epstein started warning people about the dangers of mammography, stating:
"The premenopausal breast is highly sensitive to radiation, each 1 rad exposure increasing breast cancer risk by about 1 percent, with a cumulative 10 percent increased risk for each breast over a decade's screening... The high sensitivity of the breast, especially in young women, to radiation-induced cancer was known by 1970. Nevertheless, the establishment then screened some 300,000 women with X-ray dosages so high as to increase breast cancer risk by up to 20 percent in women aged 40 to 50 who were mammogramed annually."
Since then, concerned FDA doctors and scientists have issued a number of written warnings in the form of letters to various authorities, such as the October 2008 letter to Representative Dingell, notifying him of corruption within the FDA, which sparked a House Energy and Commerce Committee investigation intoCenter for Devices and Radiological Health(CDRH) activities. 4 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn4)
A second letter, sent in January 2009 to HHS Secretary-Designate Tom Daschle, Baltimore City Health Department Chief Joshua Sharfstein, and nine members of Congress, delved into more detail. According to Medical Devices Today5 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn5):
"In the case of an April 2008 approval of a computer-aided detection device for mammography, the scientists specifically charge (by title, but not by name) ODE Director Donna-Bea Tillman "and her subordinates" with the "most outrageous misconduct by ordering, coercing, and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."
The letter also includes a bullet-pointed list of nine "examples of wrongdoing" by the ODE Director, including ordering physicians and scientists to ignore FDA guidance documents and allowing manufacturers to market unapproved devices."
In October that same year (2009), the US Preventative Task Force revised its recommendations on mammograms,6 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn6) stating that women in their 40's should no longer get routine mammograms for early detection of breast cancer. Instead, the panel recommended waiting until the age of 50, and only doing one mammogram every other year, instead of yearly. They also suggested women between 40 to 49 should talk to their doctor about the risks and benefits of the test, and then decide if they want to be screened. The Canadian task force followed suit in November last year.7 (http://articles.mercola.com/sites/articles/archive/2012/02/14/fda-secretly-monitors-personal-email.aspx?e_cid=20120214_DNL_art_1#_edn7)
Many cancer organizations were outraged and have shunned the task forces' new directive; completely ignoring the data supporting their decision... The main reason behind the changed guidelines? The inherent dangers and short-comings of mammographic screening...
__________________